An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

To join this study, you must be at least 18 years old. The most important requirement is that you must have already completed one of the previous studies involving remibrutinib for chronic hives. This study is specifically for those who have already had experience with the medication.

You also need to be willing to follow the study rules and attend all the scheduled appointments. This helps make sure that the information gathered is accurate and useful for everyone.

There are also some conditions that would prevent you from joining. For example, if you have a high risk of bleeding, a history of stomach bleeding, or need to take blood-thinning medicines, you generally won't be able to participate. Also, serious ongoing issues with your liver, heart, lungs, kidneys, or immune system, or other significant health problems that your doctor thinks would make it unsafe for you or affect the study results, would mean you can't take part. Your study doctor can discuss these points with you in detail.

If you join this study, your journey will be split into different periods. In the first period (called Epoch 1), which lasts for 24 weeks, if your hives are well controlled (meaning your Urticaria Activity Score or UAS7 is less than 16), you will have an equal chance of receiving either remibrutinib or a dummy pill (placebo). This is decided randomly, like flipping a coin, and neither you nor your doctor will know which you are getting. If your hives aren't well controlled (UAS7 16 or higher), you will openly receive remibrutinib for 24 weeks.

Throughout the study, you'll continue to take your usual background allergy medication (H1-antihistamines) if you were already on them. If your hives get worse while you're in the blinded part of the study, you'll then switch to openly receiving remibrutinib for 24 weeks.

After Epoch 1, you'll move into Epoch 2. This period involves cycles of 24 weeks. Your doctor might decide you'll have periods of not taking the study medicine to see how your hives are without it, or periods where you openly take remibrutinib again. If your hives get worse during a treatment-free period, you'll restart remibrutinib. The study duration will vary for individuals, depending on how their hives respond and their doctor's decisions, until specific study goals are met or if your hives remain very well controlled. You will have regular visits for check-ups and assessments throughout.